Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
... to the IRB, Radiation Protection Committee, Pharmacy Committee, and other similar research ... Occasional overnight and weekend travel to study meetings is required. * Previous experience in HIV ...
New
... to the IRB, Radiation Protection Committee, Pharmacy Committee, and other similar research ... Occasional overnight and weekend travel to study meetings is required. * Previous experience in HIV ...
New
... IRB/EC interactions, and study documentation.Working knowledge of FDA clinical research and medical ... Occasional overnight travel, up to 10%, may be required to support site engagement, audits ...
Quick apply
... IRB/EC interactions, and study documentation.Working knowledge of FDA clinical research and medical ... Occasional overnight travel, up to 10%, may be required to support site engagement, audits ...
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
Clinical Research Coordinator II
Boston, MA ยท On-site
$24.28 - $39.43/hr
Experience with developing REDCap projects, Epic EMR, IRB submissions (MGB Insight platform is ... Some overnight shifts may be required based on study protocols, and weekend coverage will be needed ...
Clinical Research Coordinator II
Boston, MA ยท On-site
$24.28 - $39.43/hr
Experience with developing REDCap projects, Epic EMR, IRB submissions (MGB Insight platform is ... Some overnight shifts may be required based on study protocols, and weekend coverage will be needed ...
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
... IRB/EC interactions, and study documentation. * Working knowledge of FDA clinical research and ... Occasional overnight travel, up to 10%, may be required to support site engagement, audits ...
... IRB/EC interactions, and study documentation. * Working knowledge of FDA clinical research and ... Occasional overnight travel, up to 10%, may be required to support site engagement, audits ...
Clinical Research Coordinator RN
Wilmington, NC ยท On-site
$59K - $74K/yr
No overnight travel is typically required. What You'll Do * Sets up and performs routine clinical ... Complies with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH)
Clinical Research Coordinator RN
Wilmington, NC ยท On-site
$59K - $74K/yr
No overnight travel is typically required. What You'll Do * Sets up and performs routine clinical ... Complies with all regulatory requirements related to the conduct of research (FDA, GCP, IRB, ICH)
... to the IRB, Radiation Protection Committee, Pharmacy Committee, and other similar research ... Occasional overnight and weekend travel to study meetings is required. * Previous experience in HIV ...
New
... to the IRB, Radiation Protection Committee, Pharmacy Committee, and other similar research ... Occasional overnight and weekend travel to study meetings is required. * Previous experience in HIV ...
New
... IRB/EC interactions, and study documentation. * Working knowledge of FDA clinical research and ... Occasional overnight travel, up to 10%, may be required to support site engagement, audits ...
... IRB/EC interactions, and study documentation. * Working knowledge of FDA clinical research and ... Occasional overnight travel, up to 10%, may be required to support site engagement, audits ...
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics ... Ability to travel domestically and internationally including overnight stays Competencies:
Postdoctoral Scholar - Florida Center for Prevention Research (Full-time, OPS) (Multiple Vacancies)
Tallahassee, FL ยท On-site
Prepare, submit, and amend IRB protocol and data use agreements related to opioid and substance use ... Availability to travel and participate in occasional overnight, out-of-town meetings and ...
Postdoctoral Scholar - Florida Center for Prevention Research (Full-time, OPS) (Multiple Vacancies)
Tallahassee, FL ยท On-site
Prepare, submit, and amend IRB protocol and data use agreements related to opioid and substance use ... Availability to travel and participate in occasional overnight, out-of-town meetings and ...
Overnight Irb information
What is the difference between Overnight Irb vs IRB Coordinator?
| Aspect | Overnight Irb | IRB Coordinator |
|---|---|---|
| Credentials | Typically requires IRB approval experience, research ethics knowledge | Requires IRB approval experience, research compliance certifications |
| Work Environment | Night shifts, hospital or research facility settings | Day shifts, office or administrative settings within research institutions |
| Employer & Industry | Hospitals, research institutions, clinical research organizations | Academic institutions, hospitals, research organizations |
Overnight IRB professionals focus on reviewing and approving research protocols during night shifts, often working directly with research teams in clinical settings. IRB Coordinators handle administrative tasks related to IRB submissions and compliance during regular hours. Both roles require knowledge of research ethics and IRB processes but differ mainly in work hours and specific responsibilities.
What cities are hiring for Overnight Irb jobs?
Cities with the most Overnight Irb job openings:
What are the most commonly searched types of Irb jobs?
The most popular types of Irb jobs are:
What states have the most Overnight Irb jobs?
States with the most job openings for Overnight Irb jobs include:
What job categories do people searching Overnight Irb jobs look for?
The top searched job categories for Overnight Irb jobs are:
- Biomedical Research Assistant
- Seasonal Clinical Study Startup
- Redcap Staffing
- Overnight Clinical Research Coordinator
- Clinical Research Wearable Devices
- Medical Device Clinical Research Manager
- Institutional Review Board Irb Coordinator
- Full Time Clinical Research Dental
- Hourly Ucsf Research Assistant
- Education Research Positions

Full-time
Medical, Life, Retirement, PTO
Re-posted 11 days ago
Job description
Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
Essential functions of the job include but are not limited to:
- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
- Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
- Generate potential site list from key stakeholders and drive site feasibility process
- Identify potential risks to the enrollment targets based on feasibility analysis and site`s contracted commitment
- Develop and finalize the country recruitment/retention strategy
- Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
- Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
- Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
- Support in planning and conducting investigator meetings
- Review and/or approve of IP release packages
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
- Responsible for eTMF implementation and management
- Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
- Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
- Work closely with PM for project-specific resourcing issues
- Escalate pertinent CRA performance and site compliance issues when necessary
- Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
- Manage processes for investigational product (IP) including drug accountability and reconciliation
- When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
- Support business development and marketing activities as appropriate
- May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
- May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
- May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
- May perform clinical data review of patient profiles, data listings and summary tables, including query generation
- May have line management responsibilities
- Performs other duties as assigned by management
Qualifications:
Minimum Required:
- Bachelor`s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
- Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
Preferred:
- Advanced degree
Other Required:
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
Competencies:
- Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement
- Working knowledge of clinical management techniques and tools
- Direct work experience in a cross-functional environment
- Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics
- Proven experience in planning, risk management and change management
- High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
- Ability to lead and inspire excellence within a team
- Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
- Results oriented, accountable, motivated and flexible
- Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
- Excellent presentation, verbal and written communications skills
- In depth proven experience in pharmaceutical and/or device research required
- Demonstrated successful independent negotiation and conflict management strategies
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$110,700- $200,900 USD
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About Precision for Medicine
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
501 - 1,000 Employees
Headquarters location
Bethesda, MD, US
Year founded
2012